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Melody Transcatheter Pulmonary Valve (TPV) Study: Post Approval Study of the Original Investigational Device Exemption (IDE) Cohort

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740870
First Posted: August 25, 2008
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular
Results First Submitted: April 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Congenital Heart Defects
Dysfunctional Right Ventricular Outflow Tract Conduits
Intervention: Device: Transcatheter Pulmonary Valve replacement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Enrolled All subjects enrolled (n=171)

Participant Flow:   Overall Study
    Enrolled
STARTED   171 
COMPLETED   150 
NOT COMPLETED   21 
Not Catheterized                4 
Further testing contraindicated implant                17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All stubjects enrolled

Reporting Groups
  Description
Enrolled Cohort All subjects enrolled

Baseline Measures
   Enrolled Cohort 
Overall Participants Analyzed 
[Units: Participants]
 171 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.8  (9.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      64  37.4% 
Male      107  62.6% 
Region of Enrollment 
[Units: Participants]
 
United States   171 


  Outcome Measures
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1.  Primary:   Kaplan-Meier Freedom From TPV Dysfunction   [ Time Frame: 5 years ]

2.  Secondary:   Procedural Success   [ Time Frame: Within 24 Hours post implant ]

3.  Secondary:   Serious Procedural Adverse Event (AE)   [ Time Frame: 5 years ]

4.  Secondary:   Serious Device-related Adverse Event   [ Time Frame: 5 years ]

5.  Secondary:   Kaplan-Meier Freedom From Major Stent Fracture at 5 Years   [ Time Frame: 5 years ]

6.  Secondary:   Kaplan-Meier Freedom From Catheter Re-intervention on TPV   [ Time Frame: 5 years ]

7.  Secondary:   Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit   [ Time Frame: 5 years ]

8.  Secondary:   Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)   [ Time Frame: 5 years ]

9.  Secondary:   Functional Assessment (NYHA Classification)   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susan Patterson
Organization: Medtronic
phone: 763.526.1544
e-mail: susan.patterson@medtronic.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT00740870     History of Changes
Other Study ID Numbers: G050186
First Submitted: August 21, 2008
First Posted: August 25, 2008
Results First Submitted: April 7, 2017
Results First Posted: July 2, 2017
Last Update Posted: October 25, 2017